Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76948

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 05, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Medical Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

SurFlo IV Catheter

Z-1896-2017
Recall number
Z-1896-2017
Initiated
August 05, 2015
Classification
Class II
Status
Terminated
Quantity
2,478,200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.

Code information

PRODUCT CODE 3SR-OX2225CA 3SR-OX2419CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2419CA 3SR-OX2225CA SR-TL2225M 3SR-OX2225CA 3SR-OX2419CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA SR-TL2225M 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2419CA 3SR-OX2419CA 3SR-OX2419CA LOT NUMBER RF2727 RF2727 RG0227 RG0927 RG0927 RG1627 RG2027 RG2027 RG2327 RH0727 RH1427 RH1427 RH1427 RH2127 RH2827 RH3127 RK0427 RK0427 RK1127 RK1827 RK2527 RL0227 RL0227 RL0827 RL1527 RL2227

Distribution pattern

US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.